FDA.reportPublic FDA data

amlodipine besylate

Product NDC
52605-042
11-digit product format
526050042
Labeler code
52605
Product ID
52605-042_83e3e459-c254-45e3-a5ac-2e717e08c348
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
POLYGEN PHARMACEUTICALS INC.
Application
ANDA207821
Marketing category
ANDA
Marketing start
2016-07-11
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207821-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2016-07-11
A207821-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2016-07-11
A207821-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2016-07-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207821-001AB
A207821-002AB
A207821-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207821-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2016-07-11a50c72e98297…
2026-08-01 22:54:322026-06A207821-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2016-07-11a50c72e98297…
2026-08-01 22:54:322026-06A207821-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2016-07-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207821-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A207821-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A207821-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amlodipine besylateAMLODIPINE BESYLATEPOLYGEN PHARMACEUTICALS INC.f5fbfd12-a600-482d-a306-5d6c09ae42102022-11-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207821
application number: ANDA207821
ndc (product): 52605-042

Additional Listing Data#

Finished product
Yes
Brand name base
amlodipine besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864V2Q084HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197361Internal RxNorm lookup
308135Internal RxNorm lookup
308136Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5fbfd12-a600-482d-a306-5d6c09ae4210Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52605-042-102020-10-26C16284748780-19d75b9d0-37d8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral use Initial U.S. Approval: 1992
52605-042-192020-10-26C16284748780-19d75b9d0-37d8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral use Initial U.S. Approval: 1992
52605-042-102020-01-31C16284748780-19d75b9d0-37d8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral use Initial U.S. Approval: 1992
52605-042-192020-01-31C16284748780-19d75b9d0-37d8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52605-042-10amlodipine besylate1000 in 1 BOTTLETABLET10008
52605-042-19amlodipine besylate90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52605-042AMLODIPINE BESYLATE TABLET [POLYGEN PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 2 package rows20221130_f5fbfd12-a600-482d-a306-5d6c09ae4210.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNf5fbfd12-a600-482d-a306-5d6c09ae42108
308136amLODIPine besylate 2.5 MG Oral TabletPSNf5fbfd12-a600-482d-a306-5d6c09ae42108
197361amLODIPine besylate 5 MG Oral TabletPSNf5fbfd12-a600-482d-a306-5d6c09ae42108
308135amlodipine 10 MG Oral TabletSCDf5fbfd12-a600-482d-a306-5d6c09ae42108
308136amlodipine 2.5 MG Oral TabletSCDf5fbfd12-a600-482d-a306-5d6c09ae42108
197361amlodipine 5 MG Oral TabletSCDf5fbfd12-a600-482d-a306-5d6c09ae42108
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYf5fbfd12-a600-482d-a306-5d6c09ae42108
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYf5fbfd12-a600-482d-a306-5d6c09ae42108
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYf5fbfd12-a600-482d-a306-5d6c09ae42108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52605-042-10526050042101000 TABLET in 1 BOTTLE (52605-042-10) 1000 tablet2016-07-110000-00-00NoNoCurrent
52605-042-195260500421990 TABLET in 1 BOTTLE (52605-042-19) 90 tablet2016-07-110000-00-00NoNoCurrent